This page provides a current summary of the status of ongoing and completed NICEATM-ICCVAM alternative test
method evaluation projects for which U.S. regulatory agency endorsement has been received or is pending, as well as projects to which NICEATM, ICCVAM,
and agency scientists are contributing.
View summary of status of all ongoing and completed NICEATM-ICCVAM test method evaluations
Alternative test methods:
- Reduce the number of animals used to the minimum number
required to obtain scientifically valid data
- Refine procedures to lessen or eliminate animal
pain and distress
- Replace animals with non-animal systems or one
animal species with a less highly developed one
(for example, replacing a mouse with a fish).
More information about the ICCVAM Test Method Evaluation Process
View status of test method evaluation projects grouped by project area
Select project name in summary table to jump down the page to details and links
Acute Oral Systemic Toxicity Projects |
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
Up-and-Down Procedure |
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2002 |
2002 |
. |
Fixed Dose Procedure |
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2002 |
2002 |
. |
Acute Toxic Class Method |
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2002 |
2002 |
. |
In Vitro
Cytotoxicity Test Methods: 3T3 Cells |
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2008 |
In progress |
. |
In Vitro
Cytotoxicity Test Methods: NHK Cells |
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2008 |
In progress |
. |
Biologics Projects
|
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
Use of Humane Endpoints in Animal Testing of Veterinary Products |
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2004 |
. |
. |
Use of Humane Endpoints in Animal Testing of Rabies Vaccines |
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2004 |
. |
. |
Dermal Corrosivity Projects |
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
Corrositex® Assay |
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2000 |
2006 |
. |
EpiDermTM Assay |
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2004 |
2004 |
. |
EPISKINTM Assay |
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2004 |
2004 |
. |
Rat Transcutaneal Electrical Resistance Assay |
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2004 |
2004 |
. |
SkinEthic RHE Assay |
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2004 |
2004 |
. |
Immunotoxicity Projects |
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
Murine Local Lymph Node Assay (LLNA) |
|
|
|
|
1999 |
2002 |
. |
Ocular Toxicity Projects |
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
Bovine Corneal Opacity and Permeability (BCOP) - Ocular Corrosivity |
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|
|
2008 |
In progress |
. |
Isolated Chicken Eye (ICE) - Ocular Corrosivity |
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2008 |
In progress |
. |
Pyrogenicity Projects |
Test Method |
R&D |
Validation Studies |
Evaluation |
Recommendations for U.S. Agencies |
U.S. Acceptance |
International Acceptance |
Additional Activities |
The Human Whole Blood/IL-1 In Vitro Pyrogen Test |
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In progress |
. |
. |
The Human Whole Blood/ IL-1 In Vitro Pyrogen Test Using Cryopreserved Human Whole Blood |
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In progress |
. |
. |
The Human Whole Blood/IL-6 In Vitro Pyrogen Test (WB/IL-6) |
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In progress |
. |
. |
In Vitro Pyrogen Test Using Human Peripheral Blood Mononuclear Cells (PBMC/IL-6) |
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In progress |
. |
. |
An Alternative In Vitro Pyrogen Test Using the Human Monocytoid Cell Line MONO MAC 6 (MM6/IL-6) |
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In progress |
. |
. |
Back to top
Acute Oral Systemic Toxicity
Up-And-Down Procedure
Acute oral systemic toxicity testing identifies substances that are
poisonous when ingested so that they may be appropriately labeled and packaged. The
Up-And-Down Procedure reduces animal use for this purpose by up to 70%. |
Milestone |
Date |
Document Link or More Information |
Publication of OECD Test Guideline 425 |
1998 |
PDF |
Nomination by the U.S. Environmental Protection Agency (EPA) |
August 1999 |
- |
Peer Review Panel Meeting |
July 2000 |
HTML |
Peer Review Panel Follow-up Teleconference |
August 2001 |
HTML |
Test Method Evaluation Report Published |
November 2001 |
Vol 1 -
Vol 2 |
Recommendations Made to Federal Agencies |
March 2003 |
HTML |
Federal Agency Responses Received |
December 2003 |
HTML |
Fixed Dose Procedure
Acute oral systemic toxicity testing identifies substances that are
poisonous when ingested so that they may be appropriately labeled and packaged. The
Fixed Dose Procedure reduces animal use for this purpose by up to 70%. |
Milestone |
Date |
Document Link or More Information |
Publication of OECD Test Guideline 420 |
1998 |
PDF |
Acute Toxic Class Method
Acute oral systemic toxicity testing identifies substances that are
poisonous when ingested so that they may be appropriately labeled and packaged. The
Acute Toxic Class Method reduces animal use for this purpose by up to 70%. |
Milestone |
Date |
Document Link or More Information |
Publication of OECD Test Guideline 423 |
1998 |
PDF |
Back to top
Evaluation of In Vitro Cytotoxicity Test Methods
Acute oral systemic toxicity testing identifies substances that are
poisonous when ingested so that they may be appropriately labeled and packaged.
In Vitro Cytotoxicity Test Methods replace animal use for initial dose setting for these tests. |
Milestone |
Date |
Document Link or More Information |
EPA Nomination |
August 1999 |
- |
Workshop Held |
October 2000 |
HTML |
Guidance Document Published |
August 2001 |
PDF |
Workshop Report Published |
August 2001 |
PDF |
Recommendations Made to Federal Agencies |
March 2003 |
HTML |
Federal Agency Responses Received |
December 2003 |
HTML |
Validation Study of In Vitro Cytotoxicity Test Methods
Acute oral systemic toxicity testing identifies substances that are
poisonous when ingested so that they may be appropriately labeled and packaged.
Neutral Red Uptake Test Methods replace animal use for initial dose setting for these tests. |
Milestone |
Date |
Document Link or More Information |
Peer Review Panel Meeting |
May 2006 |
HTML |
Peer Review Panel Report Published |
June 2006 |
PDF |
Background Review Document Published |
November 2006 |
Vol 1
- Vol 2 |
Test Method Evaluation Report Published |
November 2006 |
HTML |
Recommendations Made to Federal Agencies |
March 2008 |
HTML |
Federal Agency Responses Received |
September 2008 |
HTML |
Back to top
Biologics
Use of Humane Endpoints in Animal Testing of
Veterinary Products and Rabies Vaccines
Animal testing of biological products and rabies vaccines is performed
to ensure that each lot of these products is safe and effective.
A USDA directive refines animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
USDA Directive Published |
April 2004 |
PDF |
Back to top
Dermal Corrosivity
Evaluation of Corrositex® for the
Identification of Substances Potentially Corrosive to Human Skin
Dermal corrosivity testing identifies substances that cause
chemical burns to the skin so that they may be appropriately labeled and packaged.
Corrositex® reduces and refines animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
Corrositex® Submission |
May 1998 |
- |
Peer Review Panel Meeting |
January 1999 |
HTML |
Peer Review Panel Report Published |
June 1999 |
PDF |
Recommendations Made to Federal Agencies |
June 1999 |
- |
Federal Agency Responses Received |
October 1999 |
HTML |
Publication of OECD Test Guideline 435 |
July 2006 |
PDF |
Evaluation of EpiSkinTM,
EPIDERMTM and the Rat Skin Transcutaneous Electrical Resistance Assay (TER) for the
Identification of Substances Potentially Corrosive to Human Skin
Dermal corrosivity testing identifies substances that cause
chemical burns to the skin so that they may be appropriately labeled and packaged.
Use of these in vitro tests reduces and refines animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
Background Review Document Published |
August 2001 |
PDF |
Test Method Evaluation Report Published |
June 2002 |
HTML |
Recommended Performance Standards Published |
May 2004 |
PDF |
Publication of OECD Test Guidelines 430 and 431 |
July 2006 |
TG 430 - PDF
TG 431 - PDF |
Back to top
Immunotoxicity
Murine Local Lymph Node Assay (LLNA)
Immunotoxicity testing identifies substances that may
act as sensitizers and cause the development of allergic contact dermatitis.
Use of the LLNA reduces and refines animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
Nomination by Sponsors |
January 1998 |
- |
Peer Review Panel Meeting |
September 1998 |
HTML |
Peer Review Panel Report |
February 1999 |
PDF |
Recommendations Made to Federal Agencies |
February 1999 |
HTML |
Publication of OECD Test Guideline 429 |
July 2006 |
PDF |
Back to top
Ocular Toxicity
In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants
- Bovine Corneal Opacity and Permeability Test Method
- Isolated Chicken Eye Test Method
- Isolated Rabbit Eye Test Method
- Hen's Egg Test - Chorioallantoic Membrane Test Method
Ocular toxicity testing identifies substances that may
cause permanent or temporary blindness.
Use of these in vitro test methods will reduce and refine animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
EPA Nomination |
October 2003 |
- |
Expert Panel Meeting |
January 2005 |
HTML |
Expert Panel Report |
March 2005 |
PDF |
Expert Panel Teleconference |
September 2005 |
HTML |
Expert Panel Report Addendum |
November 2005 |
PDF |
Background Review Documents Published |
October 2007 |
HTML |
Test Method Evaluation Report Published |
October 2007 |
HTML |
Recommendations Made to Federal Agencies |
October 2007 |
HTML |
Federal Agency Responses Received |
May 2008 |
HTML |
Draft OECD Test Guidelines Submitted to U.S. National Coordinator |
August 2008 |
HTML |
Draft OECD Test Guidelines Accepted by National Coordinators |
March 2009 |
HTML |
Back to top
Pyrogenicity
In Vitro Pyrogen Test Methods
- The Human Whole Blood/IL-1 In Vitro Pyrogen Test
- The Human Whole Blood/ IL-1 In Vitro Pyrogen Test Using Cryopreserved Human Whole Blood
- The Human Whole Blood/IL-6 In Vitro Pyrogen Test (WB/IL-6)
- In Vitro Pyrogen Test Using Human Peripheral Blood Mononuclear Cells (PBMC/IL-6)
- An Alternative In Vitro Pyrogen Test Using the Human Monocytoid Cell Line MONO MAC 6 (MM6/IL-6)
Pyrogenicity testing is performed
on products to be administered by injection to ensure that each lot of these products
is free of substances that could induce a dangerous fever reaction.
Use of these in vitro tests could replace animal use for this purpose. |
Milestone |
Date |
Document Link or More Information |
Submission by ECVAM |
June 2005 |
PDF |
Peer Review Panel Meeting |
February 2007 |
HTML |
Peer Review Panel Report Published |
April 2007 |
PDF |
Background Review Document Published |
October 2008 |
HTML |
Test Method Evaluation Report Published |
October 2008 |
HTML |
Federal Agency Responses Received |
May 2009 |
HTML |
|